TesoRx Pharma, LLC and CoreRx, Inc. today announced a manufacturing joint venture to produce TSX-002, a first-in-class oral testosterone drug targeting the $2.5Billion low testosterone market. TesoRx’s novel, proprietary formulation orally delivers therapeutic levels of unmodified testosterone in a safe and convenient manner. The company will be commencing its final Phase 3 Clinical Study in Q1 of 2014.
“This joint venture solidifies our ability to manufacture TSX-002 to the highest standards in an environment that can easily scale from our current level through Phase 3 and, ultimately, commercial release,” said Ramachandran “TR” Thirucote, Ph.D., CEO of TesoRx. “The CoreRx team has set itself apart with its service commitment and innovation, making them an obvious choice as TesoRx moves to the next phase of development.”
“This project represents a significant expansion in both the size and mission of CoreRx,” said Todd R. Daviau, President and CEO. “An oral therapy is long overdue in the treatment of male hormone deficiency and is the cornerstone of TesoRx’s current portfolio. We are happy to have been chosen as TesoRx’s development partner and are looking forward to this long-term manufacturing project with TesoRx.”
The acquisition of the Myerlake II site will add approximately 47,000 sq.ft. of additional manufacturing and office space. TesoRx plans to begin construction in the buildings across from CoreRx’s current 35,000 sq.ft. facility in the ICOT Center campus. It will house several additional suites dedicated to process development, clinical trial manufacturing and commercial manufacturing of hormone products.
Work on the expansion has already begun and should be completed by the middle of Q2 2014.
About TesoRx, Inc.
TesoRx is a privately held pharmaceutical company focused on the development of a first-in-class unmodified oral testosterone for androgen deficiency. The company is advancing its proprietary pro-liposomal formulation of testosterone (TSX-002), through Phase 2 clinical studies for low testosterone in adult males. TSX-002 has the potential to be the first unmodified testosterone for oral delivery to enter the international market. The US market for topical, transdermal and injectable testosterone formulations alone is currently estimated at US $2.5 Billion with prescriptions having grown 34% over the last 12 months.
About CoreRx, Inc.
CoreRx is a contract research organization providing customized pre-formulation services, formulation development, manufacturing, and analytical services to pharmaceutical, biotechnology, academic, and veterinary clients. The company is renowned for reliably expediting early development activities to speed potential drugs to clinical trials while applying stage-specific scientific knowledge and experience. CoreRx's unique corporate structure creates project teams that work intensively with each client, bringing an extension of its own organization into the CoreRx lab.
Keep on top of new developments at CoreRx and throughout the drug development industry by following http://www.twitter.com/CoreRx and for more detailed information about the company, visit http://www.corerxpharma.com.
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